ESRD Clinical Trial
— EnhanceOfficial title:
Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients: Randomized Controlled Trial (Enhance Study)
This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis
Status | Recruiting |
Enrollment | 175 |
Est. completion date | December 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Received kidney replacement therapy with dialysis for more than 1 month. - Hemodialysis at least 3 times a week - (Kt/v) greater than 1.2 - Never received an organ transplant. - Life expectancy of more than 1 year - Research participants or representatives are welcome to join the project by signing. Exclusion Criteria: - History of any vaccinations in the 4 weeks prior to the study. - History of receiving influenza vaccine 6 months before entering this study. - History of allergy to flu vaccine or allergic to egg white - Fever or headache, muscle pain (influenza-like illness) 3 days before vaccination - Thrombocytopenia - On immunosuppressive drug (Prednisolone 15 mg daily or equivalent for two weeks in a row in the previous 3 months) or immunocompromised patient - Patient or family history of having had Guillain-Barre disease. (Guillain-Barre syndrome) - The research participant or his representative refuses or requests to withdraw. |
Country | Name | City | State |
---|---|---|---|
Thailand | Angsana Phuphuakrat | Ratchathewi | ?Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand |
Thailand,
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Fernández-Fresnedo G, Ramos MA, González-Pardo MC, de Francisco AL, López-Hoyos M, Arias M. B lymphopenia in uremia is related to an accelerated in vitro apoptosis and dysregulation of Bcl-2. Nephrol Dial Transplant. 2000 Apr;15(4):502-10. — View Citation
Gilbertson DT, Unruh M, McBean AM, Kausz AT, Snyder JJ, Collins AJ. Influenza vaccine delivery and effectiveness in end-stage renal disease. Kidney Int. 2003 Feb;63(2):738-43. — View Citation
Girndt M, Sester M, Sester U, Kaul H, Köhler H. Molecular aspects of T- and B-cell function in uremia. Kidney Int Suppl. 2001 Feb;78:S206-11. Review. — View Citation
Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR Morb Mortal Wkly Rep. 2015 Aug 7;64(30):818-25. — View Citation
Liao Z, Xu X, Liang Y, Xiong Y, Chen R, Ni J. Effect of a booster dose of influenza vaccine in patients with hemodialysis, peritoneal dialysis and renal transplant recipients: A systematic literature review and meta-analysis. Hum Vaccin Immunother. 2016 Nov;12(11):2909-2915. Epub 2016 Jul 8. Review. — View Citation
Lim WH, Kireta S, Leedham E, Russ GR, Coates PT. Uremia impairs monocyte and monocyte-derived dendritic cell function in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1138-48. Epub 2007 Aug 29. — View Citation
McGrath LJ, Kshirsagar AV, Cole SR, Wang L, Weber DJ, Stürmer T, Brookhart MA. Influenza vaccine effectiveness in patients on hemodialysis: an analysis of a natural experiment. Arch Intern Med. 2012 Apr 9;172(7):548-54. doi: 10.1001/archinternmed.2011.2238. — View Citation
Meier P, Golshayan D, Blanc E, Pascual M, Burnier M. Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30. Retraction in: J Am Soc Nephrol. 2014 Mar;25(3):645. — View Citation
Rautenberg P, Proppe D, Schütte A, Ullmann U. Influenza subtype-specific immunoglobulin A and G responses after booster versus one double-dose vaccination in hemodialysis patients. Eur J Clin Microbiol Infect Dis. 1989 Oct;8(10):897-900. — View Citation
Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. Erratum in: Clin Infect Dis. 2014 Jul 1;59(1):144. — View Citation
Sarnak MJ, Jaber BL. Pulmonary infectious mortality among patients with end-stage renal disease. Chest. 2001 Dec;120(6):1883-7. — View Citation
Sester U, Sester M, Hauk M, Kaul H, Köhler H, Girndt M. T-cell activation follows Th1 rather than Th2 pattern in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1217-23. — View Citation
Viasus D, Garcia-Vidal C, Cruzado JM, Adamuz J, Verdaguer R, Manresa F, Dorca J, Gudiol F, Carratalà J. Epidemiology, clinical features and outcomes of pneumonia in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Sep;26(9):2899-906. doi: 10.1093/ndt/gfq798. Epub 2011 Jan 27. — View Citation
Wang IK, Lin CL, Lin PC, Liang CC, Liu YL, Chang CT, Yen TH, Morisky DE, Huang CC, Sung FC. Effectiveness of influenza vaccination in patients with end-stage renal disease receiving hemodialysis: a population-based study. PLoS One. 2013;8(3):e58317. doi: 10.1371/journal.pone.0058317. Epub 2013 Mar 13. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12 | Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at month 12 after influenza vaccination. | 12 months | |
Secondary | To compare the prevention of influenza virus infection in different doses of influenza vaccination. | to compare incidence rate of influenza infection in different doses of influenza | 12 months of data collection |
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